Effect of EPAP Device on Emphysema and Lung Bullae

Emphysema Clinical Trial

Official title:

Effect of EPAP Device on Emphysema and Lung Bullae

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04742114
• Other study ID #: QiluH 2020039123
• Status: Recruiting
• Phase: N/A
• Start date: July 31, 2021
• Est. completion date: November 20, 2022

Study information

• Verified date: March 2022
• Source: Qilu Hospital of Shandong University
• Contact: dedong ma, Doctor
• Phone: 82169333
• Email: ma[@]qiluhuxi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and the effects and of the application of Expiratory Positive Airway Pressure (EPAP) device on Dynamic Hyperinflation and dyspnea in patients with Emphysema and pulmonary bullae.

Description:

The trial will last for six months. Patients will be collected clinical and anthropometric data by using questionnaires initially. Patients will have the pulmonary function test and CT scan and conduct 6MWT every two months. And Borg scale data will be collected every two months. The application of EPAP (15cmH2O) via face mask will be randomized with the help of opaque envelopes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 20, 2022
• Est. primary completion date: November 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 75 Years

Eligibility

Inclusion Criteria:

• The patient was =75 years old
• CT examination revealed emphysema (absolute CT value =900) or bullae
• CT do not show other imaging changes of lung diseases, such as mass, exudation and interstitial changes
• No history of lung cancer, pneumonectomy, any history of cystic fibrosis, allergic alveolitis, or pulmonary fibrosis
• Patients volunteer to participate and sign informed consent

Exclusion Criteria:

• Patients with asthma, bronchiectasis, interstitial lung disease and other basic lung diseases
• Patients with heart failure
• Patients with a history of malignancy
• Patients are reluctant to participate

Related Conditions & MeSH terms

• Bullous Disease Lung
• Emphysema
• Pulmonary Emphysema

Intervention

Device:
• use the face mask with Expiratory Positive Airway Pressure(EPAP).
The subjects were divided into two groups. The first group use the face mask without EPAP, and the other group use the face mask with EPAP.
• use the face mask without Expiratory Positive Airway Pressure(EPAP).
The subjects were divided into two groups. The first group use the face mask without EPAP, and the other group use the face mask with EPAP.

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (8)

Blanch L, Bernabé F, Lucangelo U. Measurement of air trapping, intrinsic positive end-expiratory pressure, and dynamic hyperinflation in mechanically ventilated patients. Respir Care. 2005 Jan;50(1):110-23; discussion 123-4. Review. — View Citation

Dechman G, Wilson CR. Evidence underlying breathing retraining in people with stable chronic obstructive pulmonary disease. Phys Ther. 2004 Dec;84(12):1189-97. Review. — View Citation

Fagevik Olsén M, Lannefors L, Westerdahl E. Positive expiratory pressure - Common clinical applications and physiological effects. Respir Med. 2015 Mar;109(3):297-307. doi: 10.1016/j.rmed.2014.11.003. Epub 2014 Nov 12. Review. — View Citation

Gosselink R. Controlled breathing and dyspnea in patients with chronic obstructive pulmonary disease (COPD). J Rehabil Res Dev. 2003 Sep-Oct;40(5 Suppl 2):25-33. Review. — View Citation

Kondili E, Alexopoulou C, Prinianakis G, Xirouchaki N, Georgopoulos D. Pattern of lung emptying and expiratory resistance in mechanically ventilated patients with chronic obstructive pulmonary disease. Intensive Care Med. 2004 Jul;30(7):1311-8. Epub 2004 Mar 31. Erratum in: Intensive Care Med. 2004 Nov;30(11):2140. — View Citation

Puente-Maestu L, Stringer WW. Hyperinflation and its management in COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(4):381-400. Review. — View Citation

Ranieri VM, Giuliani R, Cinnella G, Pesce C, Brienza N, Ippolito EL, Pomo V, Fiore T, Gottfried SB, Brienza A. Physiologic effects of positive end-expiratory pressure in patients with chronic obstructive pulmonary disease during acute ventilatory failure and controlled mechanical ventilation. Am Rev Respir Dis. 1993 Jan;147(1):5-13. — View Citation

Wang C, Xu J, Yang L, Xu Y, Zhang X, Bai C, Kang J, Ran P, Shen H, Wen F, Huang K, Yao W, Sun T, Shan G, Yang T, Lin Y, Wu S, Zhu J, Wang R, Shi Z, Zhao J, Ye X, Song Y, Wang Q, Zhou Y, Ding L, Yang T, Chen Y, Guo Y, Xiao F, Lu Y, Peng X, Zhang B, Xiao D, Chen CS, Wang Z, Zhang H, Bu X, Zhang X, An L, Zhang S, Cao Z, Zhan Q, Yang Y, Cao B, Dai H, Liang L, He J; China Pulmonary Health Study Group. Prevalence and risk factors of chronic obstructive pulmonary disease in China (the China Pulmonary Health [CPH] study): a national cross-sectional study. Lancet. 2018 Apr 28;391(10131):1706-1717. doi: 10.1016/S0140-6736(18)30841-9. Epub 2018 Apr 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CT DICOM data	Quantitative analysis of emphysema severity will be performed on segmented lung images by using the Slicer software package. The total emphysema percentage will be defined as all lung voxels with a CT attenuation value of less than - 910 HU.	Change from Baseline CT attenuation value at 6 months.
Secondary	FVC in pulmonary function test	The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.	Change from Baseline FVC data at 2 months.
Secondary	FVC in pulmonary function test	The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.	Change from Baseline FVC data at 4 months.
Secondary	FVC in pulmonary function test	The data of the patient's FVC will be collected to evaluate the change of the patient's lung function.	Change from Baseline FVC data at 6 months.
Secondary	FVC% in pulmonary function test	The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FVC% data at 2 months.
Secondary	FVC% in pulmonary function test	The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FVC% data at 4 months.
Secondary	FVC% in pulmonary function test	The data of the patient's FVC% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FVC% data at 6 months.
Secondary	FEV1 in pulmonary function test	The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1 data at 2 months.
Secondary	FEV1 in pulmonary function test	The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1 data at 4 months.
Secondary	FEV1 in pulmonary function test	The data of the patient's FEV1 will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1 data at 6 months.
Secondary	FEV1% in pulmonary function test	The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1% data at 2 months.
Secondary	FEV1% in pulmonary function test	The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1% data at 4 months.
Secondary	FEV1% in pulmonary function test	The data of the patient's FEV1% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1% data at 6 months.
Secondary	FEV1/ FVC% in pulmonary function test	The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1/ FVC% data at 2 months.
Secondary	FEV1/ FVC% in pulmonary function test	The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1/ FVC% data at 4 months.
Secondary	FEV1/ FVC% in pulmonary function test	The data of the patient's FEV1/ FVC% will be collected to evaluate the change of the patient's lung function.	Change from Baseline FEV1/ FVC% data at 6 months.
Secondary	TLC in pulmonary function test	The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.	Change from Baseline TLC data at 2 months.
Secondary	TLC in pulmonary function test	The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.	Change from Baseline TLC data at 4 months.
Secondary	TLC in pulmonary function test	The data of the patient's TLC will be collected to evaluate the change of the patient's lung function.	Change from Baseline TLC data at 6 months.
Secondary	RV/TLC in pulmonary function test	The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.	Change from Baseline RV/TLC data at 2 months.
Secondary	RV/TLC in pulmonary function test	The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.	Change from Baseline RV/TLC data at 4 months.
Secondary	RV/TLC in pulmonary function test	The data of the patient's RV/TLC will be collected to evaluate the change of the patient's lung function.	Change from Baseline RV/TLC data at 6 months.
Secondary	FRC in pulmonary function test	The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.	Change from Baseline FRC data at 2 months.
Secondary	FRC in pulmonary function test	The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.	Change from Baseline FRC data at 4 months.
Secondary	FRC in pulmonary function test	The data of the patient's FRC will be collected to evaluate the change of the patient's lung function.	Change from Baseline FRC data at 6 months.
Secondary	ETCO2	ETCO2 data will be collected to assess changes in CO2 retention in patients.	Change from Baseline ETCO2 data at 2 months during the intervention.
Secondary	ETCO2	ETCO2 data will be collected to assess changes in CO2 retention in patients.	Change from Baseline ETCO2 data at 4 months during the intervention.
Secondary	ETCO2	ETCO2 data will be collected to assess changes in CO2 retention in patients.	Change from Baseline ETCO2 data at 6 months during the intervention.
Secondary	6 minutes walk test(6MWT)	The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients	Change from Baseline 6MWT data at 2 months during the intervention.
Secondary	6 minutes walk test(6MWT)	The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients	Change from Baseline 6MWT data at 4 months during the intervention.
Secondary	6 minutes walk test(6MWT)	The 6 minutes walk test data will be collected to assess the cardiopulmonary function of the patients	Change from Baseline 6MWT data at 6 months during the intervention.
Secondary	Borg scale score	The Borg scale data will be collected to assess changes in dyspnea.The scale scores range from 0 to 10, with 0 indicating the minimum and 10 indicating the maximum. The higher the score, the more severe the dyspnea is.	Change from Baseline Borg scale score data at 2 months during the intervention.
Secondary	Borg scale score	The Borg scale data will be collected to assess changes in dyspnea.The scale scores range from 0 to 10, with 0 indicating the minimum and 10 indicating the maximum. The higher the score, the more severe the dyspnea is.	Change from Baseline Borg scale score data at 4 months during the intervention.
Secondary	Borg scale score	The Borg scale data will be collected to assess changes in dyspnea.The scale scores range from 0 to 10, with 0 indicating the minimum and 10 indicating the maximum. The higher the score, the more severe the dyspnea is.	Change from Baseline Borg scale score data at 6 months during the intervention.